For in vitro diagnostic use. Others LightMix in-vitro diagnostics kit PAI-1 CE-IVD IVD LightMix® in-vitro diagnostics kit PAI-1 CE-IVD 100 1377683945183 This product is not a Roche product, Roche Global Customer Support is not offering any Support. For any additional information and support please ONLY contact TIB MolBiol directly. Furthermore we can not guarantee that all available information for this product is up to date. TIBMOLBIOL-0118 Detection of the 4G/5G DNA variation in the PAI-1 genefor use with the Roche Diagnostics LightCycler® Instruments 06 896 359 001 6 896 359 001 06896359001 6896359001 06896359001 LightMix PAI-4G/5G LightMix PAI-4G/5G 04260159330472 Reagents, kits 40-0099-64 Reagents for 64 reactions Not Available false This kit allows the detection of the single-base deletion 4G/5G polymorphism in the promoter region of plasminogen-activator-inhibitor (PAI-1, OMIM: 173360) in genomic human DNA from a nucleic acid extract obtained from peripheral blood. This polymorphism at the position -675 (or -688) of the SERPINE1 gene is the major genetic determinant of PAI-1 expression. The PAI-1 promotor 4G allele is associated with increased PAI-1 transcription activity and higher PAI-1 plasma levels. Higher expression of PAI-1 negatively regulates fibrinolysis and impairs the dissolution of clots. Homozygous carriers of the 4G allele variant, and heterozygous individuals for the 4G/5G genotype with other thrombophilic risk factors, are at increased risk for thrombotic events. This product is indicated to help the clinician to analyze the genetic background of patients with: thrombophilia a family history for thrombotic events high-risk pregnancies a history of repetitive miscarriages Factor V (Leiden) mutation For heterozygous carriers of the 4G/5G genotype bearing other risk factors simultaneously, especially the Factor V (Leiden) mutation, the risk of thrombotic events increases considerably. Therefore these patients should be analyzed in addition for Factor V for example by using the LightMix® Kit 40-0594-64 (Roche SAP No.: 06896529001). The kit is not intended to be the only basis for therapy decision. The patient ́s mutation status should be considered alongside other disease factors. Note: The performance of the assay can be guaranteed only when used with LightCycler ® Instruments (see 1.3.2 for details). en Using PCR methodology, a 345 bp fragment of the PAI-1 gene is amplified with specific primers. The PCR fragment is analyzed using an internally labeled SimpleProbe® oligomer binding to the region spanning the mutation site.During the melting curve analysis the temperature is slowly increased. The probe leaves at a specific temperature (Tm) causing a fluorescence decrease. Any mismatch covered by the probe destabilizes the hybrid and lowers the Tm.In this product the probe matches the sequence of the 5G/5G genotype and the presence of the 4G/4G variant will yield a reduced Tm.Reading of the genotype results is based on the melting temperatures compared to the supplied standards. If permitted by the instrument software reading of the genotype results can be achieved by the automated genotyping module (instrument-dependent: software module 'Melt Curve Genotyping').Automated genotyping results must be reviewed by eye for deviating curves and intermediate melting point temperatures. In case that automated typing fails to report consistent genotype results, the genotype must be deduced from the melting temperatures following the criteria described in the method sheet, chapter 7. en A total number of 132 different genomic DNA samples from Caucasian origin individuals were analyzed with the present kit and compared with ABI 3730xl DNA sequencing performed by LGC Genomics GmbH, Berlin.Study results: results for both analytical methods were in 100 % concordance. In particular, 27 (20.5 %) samples were homozygous for 4G/4G, 74 (56.1 %) samples were heterozygous 4G/5G, and 31 (23.5 %) samples were homozygous 5G/5G. en

LightMix^® in-vitro diagnostics kit PAI-1 CE-IVD

Detection of the 4G/5G DNA variation in the PAI-1 gene
for use with the Roche Diagnostics LightCycler^® Instruments

IVD

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LightMix^® in-vitro diagnostics kit PAI-1 CE-IVD

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